Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

No Implant Attempt

Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized

Unsuccessful Implants

Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted

CRT-P: Biventricular Pacing Arm

Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing

CRT-P: Right Ventricular Pacing Arm

Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing

CRT-P: Not Randomized

Subjects successfully implanted with a CRT-P device who were not randomized

CRT-D: Biventricular Pacing Arm

Subjects implanted with a CRT-D device and randomized to receive biventricular pacing

CRT-D: Right Ventricular Pacing Arm

Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.

CRT-D: Not Randomized

Subjects successfully implanted with a CRT-D device who were not randomized

Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index [ Time Frame: Participants were followed for the duration of the study, an average of 39.8 months post-randomization. ]

The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.

Time Frame

Randomization to 18 Months

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Statistical Analysis 1 for Change in Cardiac Index From Randomization to 18 Months

Groups [1]

All groups

Method [2]

Bayesian Credible Interval

Posterior BiV - RV Mean Difference [3]

-0.081

95% Confidence Interval

-0.218 to 0.058

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Other relevant estimation information:

Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.